MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 3ML SYR L-LOCK; SYRINGE, PISTON

Model Number 1180300777

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

Customer reports: the syringes were cracked and the ones that were not, did crack when fluid was inserted.The incidents occurred from january to present with approximately 300 males and females between the ages of 30-90.There was no medical treatment necessary.Additional information received on 04/25/23 stated that the issues occurred during pain management procedures to cervical and lumbar areas.The cracked syringes did leak during use on a patient.There was no patient effected as the physician prevented any harm to the patient/s.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.There were 5 samples submitted with this complaint.A leak test was performed on the samples and no leaking was observed.A visual inspection identified a small scratch on barrel, but no crack was observed.The reported condition could not be confirmed.The exact root cause could not be determined as the reported condition could not be confirmed.The true root cause of the failure could not be determined based on available information.There were no anomalies found during a review of the dhr¿s, maintenance records or process monitoring data.There was no evidence of any systemic failure of the manufacturing process.Also, there was no trend observed.Based on the investigation and root cause analysis, the initiation of a new capa is not required.

• Brand Name: MONOJCT 3ML SYR L-LOCK
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16834456
• MDR Text Key: 314278224
• Report Number: 1017768-2023-01057
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521012301
• UDI-Public: 10884521012301
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1180300777
• Device Catalogue Number: 1180300777
• Device Lot Number: 22H061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1